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1、XXX LimitedDocume nt NameISO13485:2016 Quality Con trol ManualPage Code1/16Versio nADocume ntCodeQM-A-01Edited/Revised Date2018.10.24Issued Date2018.10.24Table of Contents1. Purpose & Scope22. Applicable Stan dards23. Busin ess Profile24. Authority & Resp on sibility25. Terms & Defin iti ons26. Poli
2、cy & Objectives37. Applicati on48. Quality Man ageme nt System49. Man ageme nt Resp on sibility610. Resource Man ageme nt811. Product Realizati on812. Purchas ing1113. Production Control / Product Identification & Traceability1214. Con trol of In specti on, Measuri ng, and Test Equipme nt1315. Measu
3、reme nt, An alysis, Improveme nt14If this man ual is prin ted, it is an UNCONTROLLED copy.Docume nt NameISO13485:2016 Quality Control ManualPage Code2/16Versio nADocume ntCodeQM-A-01Edited/Revised Date2018.10.24Issued Date2018.10.241. Purpose & ScopeThis man ual describes the Quality Man ageme nt Sy
4、stem (QMS) established by and forDon ggua n XXX Applia nces Limited.The principles and policies on which this manual is based; along with operating procedures, workin struc-ti ons, and other support ing docume nts; gover n all processes that affect quality throughout the orga ni za-ti on.2. Applicab
5、le Stan dards2.1 The QMS is structured and intended to be in compliance with the following standards.ISO 13485:2016 Medical Devices Quality Ma nageme nt Systems Requireme nts for Regulatory Purposes21 CFR Part 820 Quality System Regulation (Exclusio ns and Excepti ons no ted below.)2.2 Normative Ref
6、ere ncesISO 9000:2015 Quality Man ageme nt SystemsFun damentals and VocabularyISO 13485:2016 Medical devices Quality Ma nageme nt SystemsGuida nce on the Applicati on of ISO13485:20163. Bus in ess Profile3.1 Missi on Stateme ntTo deliver zero defects to our in ter nal and external suppliers and cust
7、omers.3.2 XXX, with one facility located at xxx, Dongguan City, Guangdong Province, China.3.3 The organizational structure is described by Dongguan XXX Appliances Limited Organization Chart.4. Authority & Respo nsibility4.1 This man ual is issued un der the authority of the Preside nt.4.2 It is the
8、responsibility of the Director of Quality, who is the designated Management Representative, to en sure that the pri nciples of this man ual, the Quality Policy, quality objectives, customer requireme nts, applicable regulatory requireme nts, and quality man ageme nt system requireme nts are promoted
9、, com-mu ni cated to and un derstood by all XXX employees.5. Terms & Defin iti ons5.1 Corrective Acti onA process improveme nt methodology aimed at ide ntify ing and elim in at ing the causes of known non-con formities to preve nt their recurre nce. A problem solvi ng process.Docume nt NameISO13485:
10、2016 Quality Con trol ManualPage Code3/16Versio nADocume ntCodeQM-A-01Edited/Revised Date2018.10.24Issued Date2018.10.245.2 Customer1. A bus in ess en tity and the in dividuals represe nting it that specify and purchase products produced byXXX.2. A bus in ess en tity con sideri ng XXX as a pote ntia
11、l supplier.5.3 Customer Complai ntA commu ni cati on from a customer express ing dissatisfacti on with product or service or a concern based on observations or perceptions of XXX ; classified as Formal Complaint, Informal Complaint, or Customer Return.5.4 Customer FeedbackCustomer assessme nt of XXX
12、s performa nee as it relates to meet ing customer requireme nts an d/or expectati ons.5.5 ProcessA set of in terrelated resources and activities; i.e. people, materials, equipme nt, en vir onment, methods;used to tran sform specific in puts into specific outputs.5.6 Product1. The end result of activ
13、ities performed and resources applied by XXX; a process output.2. Purchased goods and services.5.7 Preve ntive Acti onA process improveme nt methodology aimed at ide ntify ing and elim in at ing pote ntial causes of noncon-formities before they occur.A risk man ageme nt process.5.8 QualifiedHaving a
14、ttained the knowledge, skills, or other attributes necessary to perform a particular activity or task in accorda nee with specified requireme nts.6. Policy & Objectives6.1 Quality PolicyOur goal, at XXX, is to provide products and services that comply with applicable requireme nts and exceed our cus
15、tomers expectati ons. This will be accompfed through employee in volveme nt andongoing educati on to en sure contin uous improveme nt of our processes.This quality policy is commu ni cated to all employees as part of their trai ning, with the intent of provid-i ng a clear, com mon un dersta nding, d
16、irectly applicable to their work. The quality policy is reviewed at least once per year for con ti nuing suitability and adequacy.6.2 Quality Objectives? Only Defect -Free Product and Services shipped/provided to customers/suppliersDocume nt NameISO13485:2016 Quality Control ManualPage Code4/16Versi
17、o nADocume ntCodeQM-A-01Edited/Revised Date2018.10.24Issued Date2018.10.24Con ti nuous Improveme nt inDelivery Performa nee through the Utilizati on of Capable ProcessesMai nte nan ce/Co ntin uatio n of ISO 13485 Certification7. Applicati on7.1 The QMS described in this manual is applicable in contr
18、actual situations entailing the manufacture of comp onen ts/devices in accorda nee with customer specificati ons.7.2 ExclusionsParticular Requireme nts for Sterile Medical DevicesXXX does not perform sterilization of any kind.Record maintenance of sterilizati on process parameters is not applicable
19、to XXX.8. Quality Man ageme nt System8.1 Ge neral8.1.1 XXX has developed, documented, implemented, and maintains its QMS in accordance withISO 13485:2016, and 21 CFR Part 820.8.1.2 XXX applies a risk-based approach to the con trol of appropriate processes n eeded for the quality management system ut
20、ilizing the methods specified in ISO/IEC 31010:2009, Risk management - Risk assessme nt tech ni ques, which is used as guida nce on selecti on and applicati on of systematic tech ni ques for risk assessme nt.8.1.3 The QMS is based on a process approach to quality man ageme nt and XXX applies con ti
21、nuous process improvement methodology, i.e. the Plan-Do-Check-Act Cycle (Figure 1), to ensure its on-going effective ness.Docume nt NameISO13485:2016 Quality Control ManualPage Code5/16Versio nADocume ntCodeQM-A-01Edited/Revised Date2018.10.24Issued Date2018.10.24 Establish Objectives Adopt/Standard
22、ize Process/Chanqe (or repeat tlie cycle) Assess Situation Propose Process/Change Determine Resource Requirements Analyze Data,1 Evaluate Pooess Compare to Objectives Execute Plan Monitor/Measure OutputFigure 18.1.4 System processes, in clud ing their in terrelati on ships and correlati on to ISO 13
23、485:2016 sub-clauses, are described in the appe ndices of this man ual.8.2 Docume nt Con trol8.2.1 The docume nt system is tiered as show n in Figure 2.Figure 2Docume nt NameISO13485:2016 Quality Control ManualPage Code6/16Versio nADocume ntCodeQM-A-01Edited/Revised Date2018.10.24Issued Date2018.10.
24、24822 All docume nts compris ing the QMS; i.e. this Quality Man ual. Procedures, Work In structi ons. Forms; their curre nt revisio n level and file type are listed and con trolled.8.2.3 QMS docume nts are con trolled and revised as described in procedure Con trol of Docu-me nts.8.2.4 Records requir
25、ed by the QMS, ISO 13485:2016, and 21 CFR Part 820 are mai ntai ned in accorda nee with procedure Con trol of Records.8.3 ReferencesCon trol of Docume ntsCon trol of Records9. Man ageme nt Resp on sibility9.1 Ge neral9.1.1 XXX management is committed to the development and implementation of the QMS
26、and fullysupports maintaining its effectiveness by:? communicating, to all functions and levels withinXXX, the importance of meeting customer, appli-cableregulatory, and statutory requireme nts.? establishi ng an appropriate quality policy and me asurable objectives and en sur ing these are com-mu n
27、i cated and un derstood throughout the compa ny.? providing a framework for review of quality objectives and processes, including regularly scheduledMan ageme nt Reviews to en sure con ti nuing suitability, adequacy, and effective ness of the QMS.? ensuring the integrity of the QMS as changes are pl
28、anned and implemented.? allocat ing sufficie nt resources and provid ing educati on an d/or tra ining as required.9.1.2 Man ageme nt is ultimately resp on sible for determ ining and satisfy ing customer/product require-me nts.9.1.3 Roles, resp on sibilities, authorities, and their in terrelati on sh
29、ips are clearly defi ned, docume nted, and commu ni cated within XXX. Pers onnel who man age, perform, an d/or verify work affect ing quality have the authority and in de-pe ndence to perform these tasks effectively.9.2 The Director of Quality serves as theMan ageme nt Represe ntativeand, as such, i
30、s resp on sibleand fully authorized to man age the QMS and related matters on an ongoing basis. Roles and resp on sibili-ties in clude the follow ing.? In terprets applicable sta ndards and con tin ually verifies QMS complia nce.? En sures that required processes are docume nted, impleme nted, and maintain ed.? Advises the man ageme nt team regard ing operati on andeffective ness of the QMS and opportu ni-ties forimproveme nt.